Study of Compound Danshen Dripping Pills to Treat Acute M... | NCT03270787

Studies
Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness

NCT03270787

Sponsor

Tasly Pharmaceuticals, Inc.

Status

Completed

Last Update Posted

Sep 1, 2017Actual

Enrollment

58Actual

Phase

Phase 1Phase 2

Conditions

Acute Mountain Sickness

Interventions

Placebo
Compound danshen dripping pills

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 24, 2016Actual

Primary Completion Date

Jul 13, 2016Actual

Completion Date

Jul 13, 2017Actual

First Submitted Date

Jun 23, 2016

First Submission Date that Met QC Criteria

Aug 30, 2017

First Posted Date

Sep 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2017

Last Update Posted Date

Sep 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is to evaluate the efficacy and safety of compound danshen dripping pills in preventing and treating acute mountain sickness.

Detailed Description

Compound danshen dripping pills is mainly used for the treatment and prevention of coronary heart disease and high-risk groups ,consists of Danshen (Radix Salviae Miltiorrhizae), Sanqi (Radix Notoginseng) and borneol.Danshen is the main drug efficacy of stasis, nourishing the nerves.Pharmacological studies have shown that Danshen can improve the oxygen carrying capacity of blood, increase oxygen supply to vital organs, effectively reduce hypoxia-induced heart and other vital organs, brain and kidney damage. Danshen can activate the fibrinolytic system, reduce blood viscosity, clear the microcirculation, promote blood circulation, increasing the amount of tissue oxygen by inhibiting platelet aggregation.This study is being conducted to evaluate the efficacy and safety of compound danshen dripping pills in preventing and treating acute mountain sickness, when compared with placebo.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo Comparator	Placebo Comparator	Placebo Comparator: controlled group Placebo,10pills,tid,po	Drug: Placebo
Compound danshen dripping pills	Experimental	Compound danshen dripping pills Compound danshen dripping pills ,10pills,tid,po	Drug: Compound danshen dripping pills

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Drug: Placebo Placebo,10pills,tid,treat 1 weeks.	Placebo Comparator

Measure	Description	Time Frame
The incidence of acute mountain sickness rapid radical to an altitude of 3000m above the plateau region compared to placebo		7days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged 18-45 years，Male or female, plain natives
first stationed at high altitude above 3,000 meters
Upon physical examination before enrollment in good health
BMI 19 to 24; (weight kg / height Sqm )
voluntary signs the informed consent

Exclusion Criteria:

menstruation, pregnancy and breast-feeding women
smoking, alcohol and drug abusers
Clear history of drug allergy or allergic persons
application of various drugs (including traditional Chinese medicine) two weeks ago
Combined with severe liver and kidney dysfunction (cardiac function Grade ≥3, liver function Grade > 2 times of the upper limit of normal, Cr> upper limit of normal);
Subject with blood donation experiences or blood test experiences within three months before be selected.
C- reactive protein test results exceed the upper limit of normal.
clinically significant gastrointestinal disease, mental illness and diabetes, hyperthyroidism and other metabolic diseases;
Past suffering from cardiovascular and cerebrovascular disease
fatigue syndrome that is not by high altitude-induced
primary headache
Vomiting due to other causes, such as digestive disorders as a result of the vomiting reflex, vomiting vestibular disorders, neurotic vomiting;
Allergies
Who participated in clinical trials of other drugs within a month
blood circulation, increase immunity and antioxidant drug users

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Min Zhao, PhD	Tasly Group, Co. Ltd.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
People's Hospital of Tibet Autonomous Region		Damxung	Tibet	850000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases